119th Congress Commerce
S. 43: Skinny Labels, Big Savings Act
Introduced
- Introduced (completed)
- Passed Senate (not reached)
- Passed House (not reached)
- To the President (not reached)
- Became law (not reached)
Summary
This bill provides a statutory safe harbor from patent infringement claims for generic or biosimilar manufacturers that seek or obtain approval for skinny labels of their drugs.
Under current law, the Food and Drug Administration (FDA) may approve generic and biosimilar drugs through a process known as skinny labeling, which allows a generic manufacturer to seek approval only for approved uses of the drug that are no longer protected by patents. However, in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., a court held that a generic manufacturer may sometimes be liable for patent infringement when it markets skinny label generics.
The bill specifically lists the following as actions that are not considered infringement of a method of use claim in a patent under the Federal Food, Drug, and Cosmetic Act:
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- submitting or seeking approval of a skinny label for a generic or biosimilar drug;
- promoting or commercially marketing a drug with skinny labeling approved by the FDA; or
- describing a drug product approved by the FDA as a generic of, or therapeutically equivalent to, the branded drug.
The bill also applies the safe harbor to similar actions under the Public Health Service Act.
Written by the Congressional Research Service, Library of Congress.
Roll calls
No roll call votes have been held on this bill.
Amendments
No amendments were offered to this bill.
Cosponsors
- Susan Collins R-MEOriginal
- Tom Cotton R-AROriginal
- Peter Welch D-VTOriginal
Who scored on this bill
- 1John Hickenlooper SponsorDrew cross-party cosponsors, introduced2 events+6
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Other bills by John Hickenlooper
History
- Introduced in the Senate by John Hickenlooper.
Show the full action history (2 actions)
- Introduced in Senate
- Read twice and referred to the Committee on the Judiciary.